Health
Alzheimer's drug embrace slows down as US doctors' reluctance grows
Nine months into the U.S. launch of the first drug proven to slow the advance of Alzheimer’s, Eisai and Biogen’s Leqembi is facing an unexpected hurdle to widespread use: an entrenched belief among some doctors that treating the memory-robbing disease is futile.
Alzheimer’s experts had anticipated bottlenecks due to Leqembi’s requirements, which include additional diagnostic tests, twice-monthly infusions and regular brain scans to guard against potentially lethal side effects.
And those issues have played a role in slow adoption since the drug was approved by the U.S. Food and Drug Administration, according to interviews with 20 neurologists and geriatricians from rural, urban, academic and community practices in 19 states.
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In interviews with Reuters, seven doctors treating patients for Alzheimer’s attributed their own reluctance to prescribe Leqembi to concerns about the drug’s efficacy, cost and risks.
The use of the FDA-approved Alzheimer’s drug, Leqembi, has slowed down as doctor’s skepticism increases, while patients like Lyn Castellano in St. Louis continue to use the drug as it offers a sense of hope for her future. (Joe Castellano/Handout via REUTERS)
“I don’t think it’s a good Alzheimer’s drug. I think that’s the problem,” said Dr. James Burke, a neurologist at the Ohio State University who has been an outspoken critic of Leqembi. “It’s certainly nothing like the home run that we’re looking for.”
Another six scientists, all leaders in the field, said “therapeutic nihilism” – the belief that Alzheimer’s is a hopelessly intractable disease – was playing a bigger role than anticipated in suppressing demand from primary care doctors, geriatricians and neurologists who could be sending patients to memory specialists for treatment.
Dr. Reisa Sperling, a neurologist and Alzheimer’s researcher at Mass General Brigham in Boston, likens some doctors’ skepticism to Leqembi to fatalistic attitudes about cancer treatment 30 years ago: “You can’t really do anything about it, so why would you even want to get tested?”
Alex Scott, Eisai’s chief administrative officer, acknowledged that skepticism has weighed on the launch along with slower-than-expected adoption by large health systems.
He suggested that some of the doctors’ hesitancy could be a holdover from the decades-long journey to prove that removing the Alzheimer’s protein beta amyloid from the brain could slow the course of the disease. Before Esai released the promising results of its Leqembi trial, some thought that area of research “a fool’s errand,” Scott said.
“We are beginning to make more and more progress every single month. So we’re still quite encouraged,” Scott said. “This is a new journey, and I think it takes some time for providers to figure it out.”
‘SIGNIFICANT RISKS, MARGINAL BENEFIT’
Leqembi was the first amyloid-targeting drug granted full FDA approval after it slowed the decline in cognition in people in the early stages of Alzheimer’s by 27% in a clinical trial.
Of the 10,000 Americans the companies hoped to treat by the end of March, Eisai announced only a couple thousand had begun treatment as of the end of January. An Eisai spokeswoman declined to provide updated numbers.
Even for treatments that do not require dramatic changes to medical practice, adoption of new drugs is notoriously slow. Several studies have estimated that it can take 17 years on average for clinical research to be translated into routine practice.
The disease is estimated to affect more than 6 million Americans, according to the Alzheimer’s Association.
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Fewer than half of U.S. neurologists recommend Leqembi to patients, according to a January survey by life sciences market researcher Spherix Global Insights.
Dr. Michael Greicius, a professor at Stanford University’s Center for Memory Disorders, said there is little evidence that Leqembi benefits patients in a meaningful way.
“If we take the trial result at face value, the differences between placebo and treatment are likely small enough as to be undetectable by patients and family members or physicians,” said Greicius, who does not recommend Leqembi to patients.
He said the long wait for an Alzheimer’s drug has put doctors in the position of feeling obligated to offer a treatment “even if the evidence for it is very slim.”
Other doctors have raised concerns about the risk of brain swelling and bleeding associated with Leqembi as well as the costs associated with the $26,500 annual drug, frequent MRIs and twice-monthly infusions.
“There are significant risks associated with these drugs, there are significant costs, and I would say there is marginal benefit,” said Dr. Eric Widera, a geriatrician and professor at University of California San Francisco, referring to amyloid-lowering treatments.
In an editorial published in November in the Journal of Gerontological Nursing, Donna Fick, president of the American Geriatrics Society, advised doctors that the group recommends caution in the use of lecanemab, which is sold under the brand name of Leqembi.
“It is not yet clear whether treatments such as lecanemab that remove amyloid from the brain produce clinically important slowing of cognitive decline in Alzheimer’s disease.”
‘YOUR ENEMY IS NIHILISM’
Dr. Jonathan Liss, a neurologist from Columbus, Georgia, who serves on Eisai’s scientific advisory board and has tested Leqembi in clinical trials, said he first warned about nihilism at a November 2022 conference following a presentation of Leqembi’s breakthrough study.
Eisai had asked its scientific advisors how the drug might fare against future rivals. Liss cautioned that rivals were not the enemy; “your enemy is nihilism,’” he recalled. “All of the neurologists around the table started applauding.”
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Dr. Nathaniel Chin, a geriatrician with the University of Wisconsin’s Alzheimer’s Disease Research Center, said he was the target of negative comments on social media after he urged geriatricians to embrace such treatments in the Journal of the American Geriatrics Society.
Geriatricians, geriatric social workers and nurses objected, arguing that the drug’s statistically significant benefit was not clinically meaningful to patients, especially given the risks, he said.
“I would ask the question, ‘Is it ethical to withhold a medication that is FDA-approved and covered by insurance from someone who knows the risk and is willing to take it?’” Chin said.
Dr. Priya Singhal, executive vice president and head of development at Biogen, acknowledged some apathy among physicians about the treatment but said that infrastructure and lack of access to neurologists have been bigger issues.
Singhal said the companies are working with physician and patient advocacy groups and developing educational programs and materials aimed at diagnosing early-stage patients, managing side effects and understanding the drug’s benefits.
The companies said they intend to increase their salesforce by 30% as they aim for 100,000 patients by 2026.
For the moment, Leqembi is the only Alzheimer’s drug on the market designed to slow the course of the disease. A decision on Lilly’s donanemab has been delayed until the FDA convenes an advisory panel.
Lilly neuroscience president Anne White said in an interview that she sees doctor hesitancy as an issue that the company hopes to address by making clear which patients benefit from such treatments.
In the early stages of Alzheimer’s, many patients are still independent, and to be able to remain so for longer is very meaningful, she said.
‘PEACE AND QUIET’
Lyn Castellano, 64, who founded and ran a St. Louis breast cancer charity for 20 years and trained therapy dogs, started taking Leqembi last September, nearly a year after she found herself struggling with keeping track of appointments and was diagnosed with mild cognitive impairment.
Castellano said the prospect of bleeding in the brain – a possible side effect of the drug – was her biggest concern, but her family believed the drug may offer a chance at slowing the disease.
She is one of more than 140 patients being treated by physicians from Washington University in St. Louis, and has had 13 infusions and two MRIs without incident.
Dr. Suzanne Schindler, an Alzheimer’s researcher who is treating Castellano, said Leqembi “forces clinicians to completely change the way they have practiced medicine for many years.”
She said she is candid about Leqembi’s modest benefit as well as the risks. About 80% of those she believes are good candidates have opted for the treatment, she said.
While Castellano can’t tell if Leqembi is helping, she says the treatment has given her hope, and she doesn’t mind the twice monthly infusions.
“I get to go, sit back in a nice chair, have my dog with me and read a book for a couple hours. It’s about the only place I get some peace and quiet.”
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When someone gets a cancer diagnosis, the initial reaction is usually to undergo treatment as quickly as possible — but for some types of disease, doctors may recommend a more conservative approach.
For certain cancers, immediate or aggressive treatment can cause more harm than good, according to multiple medical experts.
For example, treating slow-growing tumors with surgery, radiation or chemotherapy could create significant side effects without a survival benefit.
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“The fact that so many cancers will never kill you is not a justification for not knowing, because there is still plenty of room for ‘watchful waiting,’ as well as interventions that may improve quality of life even if they don’t extend life,” Dr. Marc Siegel, Fox News senior medical analyst, told Fox News Digital.
This is especially true as targeted cancer treatments emerge, which are more personalized and less likely to cause severe side effects, according to the doctor.
For precancerous, very early-stage breast conditions, careful monitoring may be more prudent than immediate surgery, research shows. (iStock)
“The fact that cancers are occurring earlier is a justification for heightened screenings, not the opposite,” Siegel added. “Information is power — what you do with that information is based on clinical judgment and the art of medicine.”
Below are some types of cancer that may not warrant treatment, according to research and doctors’ guidance.
No. 1: Prostate cancer (low-risk)
While some types of prostate cancer should be treated right away, others are better addressed by “watchful waiting,” according to Sanoj Punnen, M.D., a urologic oncologist with Sylvester Comprehensive Cancer Center, part of the University of Miami Health System.
“With respect to prostate cancer, for most low-risk cancers (Gleason 6 or grade group 1), we recommend initial observation and surveillance rather than immediate treatment,” he told Fox News Digital.
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The Gleason score is a grading system that ranks prostate cancer cells in terms of how abnormal they are, with 6 being the lowest grade and 10 being the highest grade (barely resembling normal cells).
“For high-grade tumors like Gleason 8, 9 or 10, we believe they progress quickly, so we recommend treatment to prevent the risk of metastasis,” said Punnen, who is also vice chair of research and a professor with the Desai Sethi Urology Institute at UHealth. “For low-risk tumors, we think they pose little risk, so we recommend just observation.”
“The fact that cancers are occurring earlier is a justification for heightened screenings, not the opposite.”
“But in the end, we can’t be sure, so our approach to observation includes serial monitoring of cancer status with PSA, MRI and occasional biopsy to ensure the tumor isn’t progressing.”
No. 2: Ductal carcinoma in situ (DCIS)
Also known as stage 0 breast cancer, DCIS is a non-invasive disease marked by abnormal cells in the lining of the breast milk ducts. The “in situ” is Latin for “in the original place,” which indicates that the cancer has not spread outside the milk ducts.
For this precancerous, very early-stage breast condition, careful monitoring may be more prudent than immediate surgery, research shows.
While some types of prostate cancer should be treated right away, others are better addressed by “watchful waiting,” according to a urologic oncologist. (iStock)
A 2024 study by the Dana-Farber Cancer Institute found that active monitoring for DCIS resulted in similar quality of life, mental health and symptom progression over a two-year period compared to a standard surgical approach.
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“These results suggest that in the short term, active monitoring is a reasonable approach to management of low-risk DCIS,” the lead researcher said in a press release. “If longer-term follow-up supports the safety of active management from a cancer outcome standpoint, this approach could be considered as an option for women with this condition.”
“But it is also critical that we understand how women feel when they are living with this ‘watch and wait’ approach and how it impacts their overall quality of life.”
Other research has suggested that women with low-risk DCIS did not have a higher rate of invasive cancer after two years of active monitoring, although each patient should discuss their individual risk level with an oncologist.
No. 3: Indolent (slow-growing) lymphomas
Non-Hodgkin lymphoma (NHL) is a type of cancer that starts in the lymphatic system, which includes the lymph nodes, spleen, thymus, bone marrow and other tissues.
Indolent lymphomas are those that “grow and spread slowly,” according to the American Cancer Society.
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The National Comprehensive Cancer Network (NCCN) recommends watchful waiting for asymptomatic, slow-growing follicular lymphoma, as a means of avoiding the toxicity of chemotherapy and immunotherapy until it’s absolutely necessary.
The Lymphoma Research Foundation confirms that doctors recommend “active surveillance” for some patients with slow-growing lymphoma.
Indolent lymphomas are those that “grow and spread slowly,” according to the American Cancer Society. (iStock)
“This approach may be started after the initial diagnosis or after relapse, depending on the situation,” the foundation states on its website. “Active treatment is started if the patient begins to develop lymphoma-related symptoms or if there are signs that the disease is progressing.”
Treatment should be started right away for aggressive (fast-growing) lymphomas.
No. 4: Chronic lymphocytic leukemia
One of the most common adult leukemias, chronic lymphocytic leukemia (CLL) originates in white blood cells (lymphocytes) in the bone marrow and then spreads to the bloodstream, according to the American Cancer Society.
CLL tends to grow slowly, with many patients experiencing no symptoms for years. Eventually, the cancer calls can spread to the lymph nodes, liver and spleen.
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Some studies have shown that early treatment for CLL does not improve survival rates compared to observation, and that the benefits may not outweigh the risks.
In a 2023 study presented at the European Hematology Association 2023 Congress in Frankfurt, Germany, researchers found that early treatment did not prolong overall survival compared to a placebo in patients with early, asymptomatic CLL.
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“I believe it’s fair to conclude that ‘watch-and-wait’ should remain the standard of care in the era of targeted drugs,” said researcher Petra Langerbeins, M.D., when presenting the findings.
No. 5: Low-grade endometrial cancer
For most patients with endometrial cancer, surgery is the first treatment, which entails removing the uterus, fallopian tubes and ovaries, according to the American Cancer Society.
However, in certain patients with low-grade cancer, such as older people, those with “frailty” and people with major health issues, doctors may recommend deferring surgery, which can pose a high risk.
The American Thyroid Association’s guidelines officially recommend active surveillance for very low-risk microcarcinomas. (iStock)
In cases where the patient has medical comorbidities or wants to preserve fertility, hormone treatment may be used instead of surgery, per the ACS.
“It’s usually also considered for cancer that is lower-grade, low-volume and slow-growing,” the above source stated.
No. 6: Some early kidney cancers
In cases of kidney cancer with small tumors (≤3 cm) or benign lesions, doctors may recommend monitoring them instead of undergoing surgery for removal.
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The American Urological Association confirms that active surveillance is an option for some small renal masses (localized tumors).
“I believe it’s fair to conclude that ‘watch-and-wait’ should remain the standard of care in the era of targeted drugs.”
Deferred treatment is particularly recommended for older patients or those with “significant comorbidities,” research shows.
“Shared decision-making about active surveillance should consider risks of intervention/competing mortality versus potential oncologic benefits of intervention,” the UAU states in its guidance.
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Data from the Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry showed that patients with active surveillance had a 99% or greater cancer-specific survival rate — virtually the same as patients who received immediate treatment.
No. 7: Small papillary thyroid cancers
Papillary thyroid cancer (PTC), the most common type of thyroid cancer, may not warrant treatment for small tumors measuring 1 centimeter (10 mm) or less, which are called microcarcinomas.
A young multiracial female is undergoing a diagnostic medical imaging procedure in a state-of-the-art hospital setting with CT simulator. The image illustrates the use of cutting-edge technology for healthcare and treatment in a modern medical environment. The portrayal highlights precision, care, and the sophistication of contemporary medical practices. (iStock)
Research found that when using active surveillance for 10 to 20 years, less than 10% experienced significant growth, only 5% developed lymph node spread and there were no thyroid-cancer deaths.
The American Thyroid Association’s guidelines officially recommend active surveillance for very low-risk microcarcinomas.
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While many patients with low-risk tumors can safely delay treatment, this does not apply to all cancers or all patients.
As cancer behavior and personal health factors vary widely, patients should consult their doctor to determine the most appropriate course of care based on their individual risk level.
Welcome to the Brain Health Challenge! I’m Dana Smith, a reporter at The New York Times, and I’ll be your guide.
To live a healthy life, it’s crucial to have a healthy brain. In the short term, it keeps you sharp and firing on all cylinders. In the long term, it can reduce your risk of cognitive decline, dementia and stroke.
Practicing basic healthy behaviors, like eating nutritious food and getting regular exercise, is the best way to enhance your brain power and protect the longevity of your neurons. These types of lifestyle habits can benefit the brain at any age. And while they won’t guarantee that you’ll never develop dementia or another brain disease, several clinical trials have shown that they can improve cognition or slow decline.
Every day this week, you’ll do an activity that’s good for your brain, and we’ll dig into the science behind why it works. Some of these activities can provide a small immediate cognitive benefit, but the bigger reward comes from engaging in them consistently over time. So along with the neuroscience lessons, we’ll include a few tips to help you turn these actions into lasting habits.
To keep you accountable, we’re encouraging you to complete this challenge with a friend. If you don’t have a challenge buddy, no problem: We’re also turning the comments section into one big support group.
There are so many fascinating ways your daily behaviors affect your brain. Take sleep, for example.
Lots of studies have shown that getting a good night’s rest (seven to eight hours) is associated with better memory and other cognitive abilities. That’s because sleep, especially REM sleep, is when your brain transfers short-term memories — things you learned or experienced during the day — into long-term storage.
Sleep is also when your brain does its daily housekeeping. While you rest, the brain’s glymphatic system kicks into high gear, clearing out abnormal proteins and other molecular garbage, including the protein amyloid, which is a major contributor to Alzheimer’s disease. A buildup of amyloid is one reason experts think that people who routinely get less sleep have a higher risk of dementia.
What other behaviors play a big role in brain health? For today’s activity, we’re going to test your knowledge with a quiz. Share your score with your accountability partner and in the comments below — I’ll be in there too, cheering you on.
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An often-overlooked part of the body may reveal important clues about overall health.
Researchers from the University of Westminster in the U.K. discovered that the shape of the gluteus maximus muscle in the buttocks changes with age, gender, lifestyle and frailty, as well as certain conditions like osteoporosis and type 2 diabetes.
Using advanced MRI scans that create 3D images, researchers revealed “distinct” patterns in the gluteus maximus associated with type 2 diabetes.
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This suggested that the shape of the muscle, rather than the size, may “reflect underlying metabolic differences,” a press release stated.
The findings were presented in December at the annual meeting of the Radiological Society of North America (RSNA) in Chicago.
Butt shape may indicate underlying health conditions, according to new research. (iStock)
Unlike previous studies looking at muscle size or fat, the 3D imaging identified exactly where the muscle changes occur, according to the researchers.
As one of the largest muscles in the human body, the gluteus maximus “plays a key role” in metabolic health, according to lead study author E. Louise Thomas, Ph.D., professor of metabolic imaging at the University of Westminster’s School of Life Sciences.
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The researchers analyzed more than 61,000 MRI scans from a large UK health database to better understand the muscle’s structure.
The data also included the participants’ physical measurements, demographics, disease biomarkers, medical history and lifestyle habits. The researchers studied how these variables were linked to muscle shape over time.
An infographic from the Radiological Society of North America presentation displays research findings on the shape of the gluteus maximus. (RSNA)
“People with higher fitness, as measured by vigorous physical activity and hand grip strength, had a greater gluteus maximus shape, while aging, frailty and long sitting times were linked to muscle thinning,” study co-author Marjola Thanaj, Ph.D., a senior research fellow at the University of Westminster’s Research Centre for Optimal Health, said in the release.
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The researchers concluded that butt shape changes may indicate an “early functional decline” and “metabolic compromise” in type 2 diabetes patients.
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Men with type 2 diabetes showed muscle shrinkage, while women displayed enlarged muscle, likely due to “infiltration of fat” within it, according to the researchers.
These results suggest that men and women have “very different biological responses to the same disease,” Thanaj suggested.
Butt shape changes may indicate an “early functional decline” and “metabolic compromise” in type 2 diabetes patients. (iStock)
Men who were categorized as “frail” were recognized as having more “general shrinkage” across the gluteus maximus, but women experienced a “limited” frailty effect.
Building strong glutes for better health
Strengthening the glutes is an “investment in long-term health,” according to Tanya Becker, co-founder of Physique 57 in New York City.
“While full-body strength training is essential, focusing on your glutes — the largest muscle group in your body — deserves special attention,” she told Fox News Digital.
“While full-body strength training is essential, focusing on your glutes — the largest muscle group in your body — deserves special attention.” (iStock)
Becker refers to the glutes as the body’s “shock absorbers,” because they protect the lower back, knees and hips from taking on stress they weren’t designed to handle.
Larger muscle groups also burn more calories and help regulate blood sugar, the expert added, noting that muscles are often referred to as the “organ of longevity.”
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Strengthening the glutes also helps to protect the lower back, hips and knees, and also improves posture and balance, reducing the risk of falls and improving mobility.
“People with higher fitness, as measured by vigorous physical activity and hand grip strength, had a greater gluteus maximus shape.”
Becker recommends traditional weighted exercises like squats, lunges and bridges, although they are not suited for everyone, especially older adults with injuries and joint pain.
“Pilates and barre classes offer bodyweight exercises that are ideal for beginners or individuals with physical limitations,” she suggested. “They can be done anytime, anywhere, making them accessible for beginners before progressing to weighted versions.”
Glute bridges (demonstrated above) are a recommended exercise for strengthening those muscles. (iStock)
Becker shared the following three glute exercises that improve hip mobility, stability and overall strength.
No. 1: Quadruped leg lifts (strengthens entire core and glutes)
Start on the hands and knees, engage your core, and lift one leg off the floor (bent or straight). Pulse up and down a few inches for 30 to 60 seconds, then repeat on the other leg.
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No. 2: Clamshells (strengthens gluteus medius)
Lie on your side with knees bent at 90 degrees in front of you. Lift your top knee away from your bottom knee, then lower slowly.
For an increased challenge, lift both feet off the ground while keeping the heels together. Repeat for 30 to 60 seconds per side.
Strong muscles are responsible for maintaining metabolic health, according to Becker. (iStock)
No. 3: Glute bridges (strengthens lower back and glutes)
Lie on your back with knees bent and feet parallel, a few inches from your hips. Engage your abs, and squeeze your glutes to lift your hips toward knee height, then lower.
If you feel pressure in your neck, you’ve lifted too high. Perform for 30 to 60 seconds. Complete three sets with 30-second rests between them.
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Those looking to start a new fitness routine should first consult with a doctor.
Fox News Digital reached out to the study authors for comment.
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